Sterility Assurance Technician Job at Medasource, Durham, NC

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  • Medasource
  • Durham, NC

Job Description

Job Title: Sterility Assurance Technician

Schedule: Night shift including weekends, 12-hour shifts on a 2-2-3 rotation. Must be flexible to accommodate additional work in extended hours and/or off-hour work.

(6PM-6AM) and weekends.

  • Need to come in 8AM-5PM for training. Probably first two weeks, then switch to nights.

Key Responsibilities:

  • Participate in qualification and validation activities related to bioburden control strategies for facilities and equipment.
  • Execute routine sterility assurance activites
  • Support media fill simulations and provide documentation to ensure compliance with regulatory guidelines.
  • Analyze and interpret environmental monitoring data, identifying trends and potential risks to product quality.
  • Collaborate with cross-functional teams to troubleshoot contamination events and recommend corrective actions.
  • Maintain accurate records and ensure timely reporting of sterility assurance results.

Qualifications:

  • Experience in qualification or validation activities supporting contamination control measures in manufacturing facilities or equipment.
  • Comprehensive understanding of aseptic techniques, either through hands-on operational experience or involvement in media fill processes.
  • Prior experience participating in media fill simulations in a regulated environment.
  • Ability to work in a fast-paced environment with strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.

Job Tags

Flexible hours, Shift work, Weekend work,

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